Dysport® Adult Lower Limb Spasticity Follow-on Study

Completed

Phase 3 Results

Trial Description

The purpose of this research study is to assess the long term safety of Dysport® in hemiparetic subjects with lower limb spasticity due to stroke or traumatic brain injury over repeated treatment cycles.

Conditions

Interventions

  • Dysport Drug
    Intervention Desc: I.M. (intramuscular) injection on day 1 of each treatment cycle.
    ARM 1: Kind: Experimental
    Label: Dysport
    Description: Dysport is injected into lower limbs across 4 cycles of treatment, a minimum of 12 weeks between 2 injections. Doses vary from 1000 U to 1500 U.
  • Dysport® Drug
    Other Names: •AbobotulinumtoxinA (non-proprietary name)
    Intervention Desc: I.M. (intramuscular) injection on day 1 of each treatment cycle.
    ARM 1: Kind: Experimental
    Label: Dysport®
    Description: Dysport® is injected into lower limbs across 4 cycles of treatment, a minimum of 12 weeks between 2 injections. Doses vary from 1000 U to 1500 U.

Trial Design

  • Allocation: Non-Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Safety/Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety through collection of adverse events Every 4 weeks Yes
Secondary Intensity of muscle tone rated by the Modified Ashworth scale Every 4 weeks No
Secondary Physician's global assessment (PGA) of the treatment response Every 4 weeks No
Secondary Assessment of walking speed Every 4 weeks No
Primary Assessment of the Long-Term Safety of Dysport® Through the Collection of Treatment Emergent Adverse Events (TEAEs) Up to EOS (maximum duration of 52 weeks).
Primary Mean Change From Baseline to Week 4 in Systolic and Diastolic Blood Pressure (BP) Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Heart Rate (HR) Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Red Blood Cell (RBC) Count Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Haemoglobin and Mean Corpuscular Haemoglobin Concentration (MCHC) Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Haematocrit Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Mean Corpuscular Haemoglobin (MCH) Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Mean Corpuscular Volume (MCV) Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in White Blood Cell (WBC) Count, Neutrophils, Lymphocytes and Platelets Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Alkaline Phosphatase (ALP), Gamma Glutamyl Transferase (GGT), Serum Glutamic Oxaloacetic Transaminase (SGOT) and Serum Glutamic Pyruvic Transaminase (SGPT) Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Total Bilirubin and Creatinine Baseline and Week 4 of each cycle
Primary Mean Change From Baseline to Week 4 in Blood Urea Nitrogen (BUN) and Fasting Blood Glucose Baseline and Week 4 of each cycle
Primary Presence of Botulinum Toxin Type A (BTX-A) Neutralising Putative Antibodies (NAbs) Following Injection of Dysport® At Week 4
Primary Mean Change From Baseline to Week 4 in 12-Lead Electrocardiogram (ECG) Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in the Modified Ashworth Scale (MAS) Score Measured in the Gastrocnemius-soleus Complex (GSC) (Knee Extended) Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in the MAS Measured in the Soleus Muscle (Knee Flexed) Baseline and Week 4 of each cycle
Secondary Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the GSC (Knee Extended) at Week 4 Week 4 of each cycle
Secondary Percentage of Subjects With At Least a 1 or 2 Grade Reduction in the MAS Measured in the Soleus Muscle (Knee Flexed) at Week 4 Week 4 of each cycle
Secondary Physician's Global Assessment (PGA) of Treatment Response at Week 4 Week 4 of each cycle
Secondary Percentage of Subjects With a Score of at Least +1 on the PGA Scale at Week 4 Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in the Range of Active Ankle Dorsiflexion Both With the Knee Flexed and With the Knee Extended Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Lower Limb Pain Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Short Form (36) Health Survey (SF-36) Quality of Life (QoL) Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline in European Quality of Life - 5 Dimensions, 5 Level (EQ-5D-5L) QoL Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Walking Speed (WS) Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Step Length Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Cadence Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the GSC (Knee Extended) Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the GSC (Knee Extended) Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Angle of Arrest (XV1), Angle of Catch (XV3) and Spasticity Angle (X) in the Soleus Muscle (Knee Flexed) Baseline and Week 4 of each cycle
Secondary Mean Change From Baseline to Week 4 in Spasticity Grade (Y) in the Soleus Muscle (Knee Flexed) Baseline and Week 4 of each cycle
Secondary Use of Walking Aids/Orthoses at Baseline and Week 4 Baseline and Week 4 of each cycle

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